NCT04890262Completed
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice
Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes (VARIETY-AUT)
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease. In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 99 (actual)
- First submitted
- 13 May 2021
- Start date
- 18 Aug 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04890262
What you commit to
- Study type: Observational
- Participants enrolled: 99
- From 18 Aug 2021 to the primary completion date, 30 Jun 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
Other
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 1\. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| JKU Linz Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Krankenhaus der Barmherzigen Bruder Coordinator of this site? Confirm its status | Saint Veit/Glan | Austria | Unknown status |
| Darmpraxis Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.